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Govts or manufacturers, who is on the hook if Covid-19 vaccines go wrong?

Policy makers in developing nations may not have a choice but to take what they can get - easily, cheaply and quickly

Coronavirus Vaccine | Coronavirus | Pharma industry

Anjani Trivedi & Andy Mukherjee | Bloomberg 

vaccine, pharma, cold storage, cold chains, coronavirus, medicine, drugs, medical research, covid, lab
Who will be responsible if there are serious adverse side events? No insurer will underwrite the risk; the burden of compensation will fall on states or, in the case of poor countries, on Covax

The Covid-19 vaccines are here and distribution has begun. But what if something goes wrong?

Whether it’s a loss of income, hefty medical bills or other serious adverse effects, someone has to pick up the tab. In the past, so-called liability shields have given companies cover to produce effective treatments quickly without legal exposure. But it’s a risky endeavour for nations to absorb responsibility for highly novel products, developed and licensed at lightning speed.

Who will be responsible if there are serious adverse side events? No insurer will underwrite the risk; the burden of compensation will fall on states or, in the case of poor countries, on Covax, a global initiative to ensure equitable distribution. On current estimates, Covax can meet only a fifth of global demand by the end of the year. So countries that are striking direct agreements with producers will still have to worry about potential tort claims, which seek civil remedies. The virus may stick around even after universal immunisation, with mutant strains creating an enduring market for jabs long after Covid has ceased to be a health emergency.

Manufacturers, distributors and other entities in the US “are very likely to find their Covid-19 products and services moving across borders”, according to RAND Corporation researchers. Their legal exposure in foreign courts is thus uncertain, especially given the rapid pace of vaccine development and limited data about side effects.

Going by past pandemics, this data won’t start showing up for a while. When it does, it will likely vary by country, which affects how liability is handled. In 2013, four years after swine flu hit the globe, the UK government reversed its stand on the safety of the Pandemrix jab made by GlaxoSmithKline, after a major study showed that it was associated with narcolepsy. Affected individuals could apply for compensation. At the time, the health department noted that “the decision to recommend that children got this vaccine during the flu pandemic was based on evidence available at the time, along with the advice from the European Medicines Agency which approved its use”. It then said that the department keeps “all emerging evidence under review”, which is why usage stopped in 2011 for those under 20. The data evolves, muddying potential liability issues.

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It gets more complicated. Rich countries are buying up large doses of viable vaccines from Pfizer-BioNTech and Moderna. Many are now weighing turning over a portion they have secured to low- and middle-income nations facing delays as Covax hasn’t worked out as planned. With altruistic gifts, it’s even harder to assign responsibility.

During the H1N1 pandemic of 2009, the World Heath Organization came up with a multi-country liability shield, as RAND researchers describe it, or a global legal framework. Recipient countries had to sign a letter of agreement that allowed donors to wash their hands of liability, or indemnify donors, as long as they followed WHO standards. Eventually, of the 94 countries that were interested in donations, 87 signed the agreement and only 78 completed the preconditions in the agreement for vaccine supply.

The complexity of the current situation and the sheer scale of production mean a new agreement will be required. National governments will need to negotiate, consider and approve various requirements — all long processes. If disparities between countries crop up, manufacturers will face barriers to production and distribution.

Previous widespread illnesses like small pox and other influenzas show that liability issues can hinder progress of new vaccines, even domestically.

An additional challenge this time around is the space race-type competition. All this is too breathtaking for scientists. Policy makers in developing nations may not have a choice but to take what they can get — easily, cheaply and quickly. But in so doing, they might just be storing up legal troubles for later.

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First Published: Thu, January 07 2021. 23:25 IST